Gilead has signed non-exclusive voluntary licensing agreements with Cipla, Hetero Labs, Jubilant Lifesciences, Mylan and Ferozsons Laboratories, a Pakistan based pharma firm, to manufacture remdesivir for distribution in 127 countries including India. Remdesivir has been issued an Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) to treat COVID-19 patients.
Under the licensing agreements, the companies have a right to receive a technology transfer of the Gilead manufacturing process for remdesivir to enable them to scale up production more quickly. The licensees are also allowed to set their own prices for the generic product they produce.
According to Gilead, the licenses are royalty-free until the World Health Organization declares the end of the Public Health Emergency of International Concern regarding COVID-19, or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent COVID-19, whichever is earlier.
Commenting on the partnership, Umang Vohra, MD and Global CEO, Cipla said, “As the world is faced with the COVID-19 crisis, it is imperative that we collaborate and fight this virus together. We are pleased to partner with Gilead for this cause and take this treatment to patients across countries after the required regulatory approvals. At Cipla, it is our continuous endeavour to ensure that no patient is denied access to life-saving treatments. Our partnership with Gilead represents this unwavering commitment and is a significant step towards saving millions of lives impacted by the pandemic.”
Evoking similar notions, Shyam S Bhartia, Chairman and Hari S Bhartia, Co-Chairman & Managing Director, Jubilant Life Sciences said, “We are very happy to strengthen our partnership with Gilead to license remdesivir, which, based on initial data, shows promise to be a potential therapy for COVID-19, a pandemic creating unprecedented health and economic crisis globally. We will be monitoring the clinical trials and regulatory approvals very closely and would be ready to launch the drug shortly after the required regulatory approvals. We also plan to produce the drug’s Active Pharmaceutical Ingredient in-house, helping its cost effectiveness and consistent availability.”
“Hetero is pleased to partner with Gilead to enable access for this important drug to India and other developing countries at this crucial time. This agreement also illustrates the significance of global collaboration and the need for coming together to fight the health crises impacting humanity. Hetero has developed this product in India and has already been working with the government, ICMR, and DCGI for necessary studies and approvals to bring this product to treat COVID-19 patients in India,” commented Dr B Partha Saradhi Reddy, Chairman, Hetero Group of Companies.
The EUA is based on available data from two global clinical trials – US National Institute for Allergy and Infectious Diseases’ placebo-controlled Phase 3 study in patients with moderate to severe symptoms of COVID-19, and Gilead’s global Phase 3 study evaluating Remdesivir in patients with severe disease. Multiple additional clinical trials are ongoing to generate more data on the safety and efficacy of Remdesivir as a potential treatment for COVID-19. Remdesivir continues to be an investigational drug that has not been approved by the FDA.